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510(k) Data Aggregation

    K Number
    K053250
    Device Name
    ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Date Cleared
    2005-12-15

    (24 days)

    Product Code
    GZB
    Regulation Number
    882.5880
    Type
    Special
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Advanced Neuromodulation Systems 90 cm and 110 cm (3100 and 3200 Series) Leads are indicated for the management of chronic pain of the trunk and/or limbs either as the sole mitigating agent, or as an adjunct to other modes of therapy as part of a multidisciplinary approach and are intended for use with Advanced Neuromodulation Systems receivers, IPGs, transmitters, and/or antennae.

    Device Description

    Not Found

    AI/ML Overview

    This document, K053250, is a 510(k) premarket notification letter from the FDA regarding the ANS 3100 and 3200 series leads. It is primarily an approval letter and an "Indications For Use" statement. It does not contain any information about acceptance criteria, study details, or device performance data.

    Therefore, I cannot provide the requested information based on this document. To answer your questions, I would need access to the actual 510(k) submission or supporting clinical study reports for the device.

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